ENDOSCOPE LASER-TRIGGERED SUCTION AUTOMATIC ON/OFF
A suction or other component of an endoscope system may be cycled on and off or otherwise controlled without requiring direct user input, such as automatically or semi-automatically using a current or historical state of a laser generator, a blurriness or other information from an image of the working area, a count of fragments of a calculi stone, an intraoperative pressure, an intraoperative temperature, or one or more other characteristics of the laser generator or the targeted calculi stone.
This application claims priority to U.S. Provisional Patent Application Ser. No 63/262,924, filed Oct. 22, 2021, the contents of which are incorporated herein by reference.
BACKGROUNDMedical scopes such as endoscopes were first developed in the early 1800s and have been used to inspect inside the body of a patient. Such scopes can include endoscopes, laparoscopes, ureteroscopes, duodenoscopes, arthroscopes, and others, which can be referred to as endoscopes or scopes. An endoscope may be used to move fluid through an organ. Some endoscopes provide irrigation, suction, or both, such as to move the fluid. Laser energy can also be used inside the body, For example, a laser generator can provide laser energy into the body, such as via a laser fiber or fiber bundle. The laser energy can be used for diagnosis or treatment, such as to perform laser lithotripsy to ablate one or more calculi stones. The ablation can cause the stone to break apart into smaller pieces that can pass naturally or can be grasped, suctioned, or otherwise removed from the body through the endoscope or an ancillary tool.
In the drawings, which are not necessarily drawn to scale, like numerals may describe similar components in different views. Like numerals having different letter suffixes may represent different instances of similar components. The drawings illustrate generally, by way of example, but not by way of limitation, various embodiments discussed in the present document.
The systems and techniques described herein relate to medical devices, such as an endoscope, that uses aspiration or “suction” to move fluid, calculi stones, calculi dust and/or calculi fragments, or the like through an organ, such as the kidney, during lithotripsy. The suction of an endoscope can be actuated by, synchronized with, or otherwise coordinated with the laser energy delivery, although the suction may be additionally or alternatively coordinated with one or more additional or different functions. This can be done automatically—without requiring user input to control the suction.
Endoscopes may be used for visualizing an internal target for diagnosis, treatment, or both. An endoscope may be configured to facilitate fluid influx (e.g., “irrigation”) and removal (e.g., “suction”), such as to wash away debris from the organ and improve visualization during an endoscopic procedure. For example, a ureteroscope may include an irrigation fluid channel to supply saline to the kidney, and a suction channel to aspirate calculi dust and fragments during a laser lithotripsy procedure. While stone dust and small fragments may be expelled naturally by the patient, it can be beneficial to actively remove the debris during the procedure.
The inflow and outflow of fluid through the kidney may involve increases and decreases in renal pressure that may benefit from monitoring, control, or both. Having suction “on” continuously during an entire procedure may not be desirable, Suction that is always “on” may involve continuous monitoring and control or a continuous inflow of irrigation fluid to replace the fluid removed from suction. Furthermore, when dusting or other stone fragmentation is paused, suction and/or the passage of fluid through the kidney may be unnecessary during that time. Therefore, it is advantageous to control the suction such that it is activated only when needed.
The systems and techniques described herein may be used to activate endoscopic suction at times it is deemed important or desired, and to suspend suction at other times. While suction may be controlled manually by the endoscope user (e.g., using a foot pedal or other actuator), the present systems and techniques can provide a capability to automatically control suction, such as based on one or more criteria such as which do not require a separate direct user input to activate and/or deactivate suction. For example, suction can be automatically controlled based on the state of the laser or other energy source (or an associated control signal), such as being turned on in response to when a laser source is being turned on or is on during laser lithotripsy, and turned off in response to when the laser source is being turned off or is off.
A time shift delay of the suction control relative to the laser generator activation/deactivation may be provided. For example, while the suction could be automatically turned off when the laser is turned off, a programmed turn-off delay may be used to continue the suction for a period of time after the laser is turned off or a period of time before the laser is turned on. For example, the suction may remain “on” for some programmable or otherwise specified amount of time (e.g., ½ second, 1 second, X seconds, etc.) before the laser has begun delivering laser energy or after the laser has stopped delivering laser energy, such as to move the calculi stone or fragments into a desired location for ablation by energy delivery or to provide some amount of time to clear the dust/fragments after the laser activity.
One or more criteria other than time may be used as the basis for automatically delaying when suction will be suspended, such as when an image sensor has produced one or more image(s) that are deemed sufficiently clear of dust, fragments, and/or other debris. For example, a comparison of image clarity, haze, or one or more other individual or composite characteristics may be compared to a specified acceptable amount or a specified acceptable image. This can be carried out algorithmically or using a trained model such as to help determine or improve the results using artificial intelligence and/or machine learning (AI/ML).
For example, the criteria for automatically delaying when suction will be suspended may be based on a sensor-derived measurement of intraoperative pressure. For example, suction may stay on for some time after laser dusting has stopped, depending on when the intraoperative pressure has settled to some acceptable level or range.
Where irrigation or other fluid delivery is based on an active mechanism such as a pump, versus a gravity IV, fluid delivery can be similarly controlled, such as can be based at least in part on one or more laser activation times. For example, both fluid delivery and suction can be automatically suspended (e.g., without requiring any independent direct user input) when laser dusting/fragmentation has ended (or after some delay).
The endoscope system 100 may include an endoscope 102, a suction component 104, a laser generator 106, and fluid source 108. The endoscope system 100 may interact with a patient 110. For example, the endoscope system 110 may be used to access an organ of the patient 110, such as a kidney 112. The kidney 112 may have a calculi stone 114.
The endoscope 102 may include one or more channels, such as a working channel to allow a distal portion of an ancillary device to be introduced to a target site within the patient 110. Separate irrigation and suction channels may be included in the body of the endoscope 102, or such functions may be performed using the working channel of the endoscope 102. Regardless of which channel is used, a distal portion of the suction component 104, a distal portion of a laser fiber from the laser generator 106, or a distal portion of an irrigation channel in fluid communication with the fluid source 108 can be provided with access to the target site within the organ (e.g., kidney 112). The endoscope 102 may include or may be coupled via an illumination fiber or fiber bundle to an illumination light source (which may be different than the laser generator 106). This can help provide a means of illuminating the kidney 112 at the distal end of the endoscope, such as to help visual observation by the endoscope via endoscope visualization optics. The endoscope 102 may be single-use or reusable. The endoscope 102 may be flexible, such as to permit the endoscope 102 to be passed through an incision in the patient 110, through a urethra of the patient 110, or other means of accessing the kidney 112 or other target organ of the patient 110.
The irrigation fluid source 108 may provide saline or other fluid through the endoscope 102 to the procedure site within the kidney 112 or other organ. The fluid source 108 may include an intravenous (IV) bag on a pole that provides fluid due to gravity. Irrigation using the fluid source 108 may be controlled by a pressure cuff, such as that squeezes components of an intravenous bag, by raising or lowering the intravenous bag, by a thumb wheel actuator, such as that adjusts a valve opening of a valve, or other means capable of modifying the rate of providing irrigation or other fluid. The fluid source 108 may be controlled such as to continuously supply fluid. The fluid source 108 may be controlled such as to provide fluid at a constant rate. The fluid source 108 may be controlled such as to provide fluid at an adjustable or even a varying rate. The rate of flow from the fluid source 108 may be controlled manually such as by the endoscope user or another caregiver. The rate of flow from the fluid source 108 may be controlled automatically or semi-automatically, such as based on one or more detected or anticipated events, without requiring user-intervention, although such user-intervention may be permitted.
The laser generator 106 may provide energy through the endoscope 102 to the calculi stone 114, such as via one or more optical fibers or an optical fiber bundle, either of which can be referred to as a laser fiber. For example, the laser generator 106 may generate laser pulses to ablate the calculi stone 114 into smaller pieces (such as dust or fragments) that can be removed from or be passed by the patent 110. The ablation by the laser generator 106 may cause calculi dust or fragments. The calculi dust or fragments may be sized to permit natural passing of the calculi, may be removed using suction applied from the suction component 104, or may be removed with the aid of a retrieval device or other medical equipment. In some embodiments, the laser generator 106 may be substituted for (or augmented by) another energy providing source, such as an ultrasound energy source. The laser generator 106 can be controlled manually by the user to trigger delivery of the laser-energy to the target. Alternatively or additionally, the laser generator 106 may be controlled automatically, e.g., without requiring user intervention to trigger delivery of the laser-energy to the target, such as when an AI/ML or other trained model has identified a calculi stone at which the laser has been aimed. Alternatively or additionally, the laser generator 106 may be controlled semi-automatically, such as when an AI/ML or other trained model has identified a calculi stone at which the laser has been aimed, but requesting user-confirmation before actually triggering delivery of the laser energy. Alternatively or additionally, an energy level of the laser pulses issued by the laser generator 106 or a pulse repetition rate or pattern of the laser generator 106 may be determined automatically or semi-automatically. Such automatic energy level, repetition rate or pattern may be issued automatically, semi-automatically, or may be issued by a user. Controlling any of suction, irrigation, ablation, or other function may be accompanied by control of positioning or movement of endoscope 102 itself, such as in a fully robotic or robotically-assisted approach, or control of one or more other end-effectors associated with the endoscope 102.
The suction component 104 may provide suction through the endoscope 102, such as via a suction channel or a working channel of the endoscope 102, to the target or working area of the organ (e.g., kidney 112). The suction component 104 may remove fluid from the kidney 112 using suction. The suction component 104 may remove calculi dust or fragments from the kidney 112 using suction. The rate of suction may be established or adjusted such as to be substantially similar to the rate of providing irrigation or other fluid, such that the there is a substantially consistent amount of fluid in the working area and the organ. For example, if the fluid delivery rate is high, the suction rate may be high. Similarly, if the fluid rate is low, the suction rate may be low. The fluid delivery rate may be established or modified based at least in part on the suction rate. Conversely, the suction rate may be established or modified based at least in part on the fluid delivery rate.
The endoscope system 100 may include an imaging device, imaging optics, or both. For example, a camera or other imaging device may be incorporated within the endoscope 102. The imaging device may be separate from the endoscope 102—either completely separate, or separate but insertable toward the target via the endoscope 102. The imaging device may provide one or more still or video images of the working area of the organ (e.g., kidney 112). Object recognition or other image-processing may be performed on the images, such as explained herein.
The endoscope system 100 can include or be coupled to a computing device or other controller circuitry that can be implemented in hardware, software, firmware, or some combination of these. The computing device can include a processor and a memory device. The memory device can include instruction that, when performed by the processor, cause the computing device to perform a one or more acts or operations. The computing device may be capable of image processing, activating and/or deactivating the suction component 104, changing a rate of suction of the suction component 104, activating and/or deactivating the laser generator 106, changing an energy level of the laser generator 106, activating and/or deactivating the fluid source 108, changing the fluid delivery rate of the fluid source 108, receiving a sensed indication of one or more characteristics of the working environment from one or more sensors (e.g., a temperature sensor, a pressure sensor, etc.), or a combination thereof.
Timing of the suction component 104 can also be established or manipulated such as to modify the suction rate and/or to coordinate activation or amount of suction with or in response to the changing or activating/deactivating of the laser generator 106, and need not be coordinated at precisely the same time. For example, the computing device may turn off (or turn down) the suction component 104 at 204 at some difference in time after (or even before) the laser generator 106 has been turned off (or turned down) at 206. For example, the laser generator 106 may have a predetermined pattern of laser energy delivery once laser generator 106 is activated such that the computing device may turn off (or turn down) suction prior to deactivation (or decrease in laser energy) of the laser generator 106. The difference in time may additionally or alternatively be based all or in part on a time delay, a temperature at the working area, a pressure at the working area, and/or other measured characteristic. Thus, the computing device may activate (at 204) or deactivate (at 208) the suction component 104 and/or the fluid source 108 based on a combination of settings or measurements (e.g., temperature, pressure, laser energy, or other measured characteristic). For example, at 202, the laser generator 106 may begin delivering laser energy at time zero, and two seconds later, at 204, the suction component 104 and/or the fluid source 108 may be activated or increased. Similarly, at 206, the laser generator 106 may stop delivering laser energy at time x, and two second later, at 208, the suction component 104 and/or the fluid source 108 may be deactivated or decreased. As another example, the laser generator 106 may be activated, but laser energy may be set to a delay, such that suction may be activated or modified before the delivery of the laser energy. For example, the suction may move the calculi stone 114 into a location for delivery of the laser energy. Method 200 may be repeated as laser generator 106 is activated and deactivated to ablate the calculi stone 114.
The imaging device can capture one or more images of the working area for the computing device to analyze, such as for using in determining how to automatically or semi-automatically control suction, irrigation, or another operating parameter.
In some embodiments, the input interface 802 may be a direct data link between the CDSS 800 and one or more medical devices that generate at least some of the input features, such as an imaging device, spectroscopic device, thermometer, pressure sensor, or other sensor to provide imaging, spectroscopic, temperature, pressure, or other characteristic information. For example, the input interface 802 may transmit laser energy status and/or characteristic information (e.g., images, temperature, pressure) directly to the CDSS during a therapeutic and/or diagnostic medical procedure. Additionally, or alternatively, the input interface 802 may be a classical user interface that facilitates interaction between a user and the CDSS 800 For example, the input interface 802 may facilitate a user interface through which the user may manually enter a laser energy treatment protocol of the laser generator 106. Additionally, or alternatively, the input interface 802 may provide the CDSS 800 with access to an electronic patient record from which one or more input features may be extracted, such as previous imaging of the working area. In any of these cases, the input interface 802 is configured to collect one or more of the following input features in association with a specific patient on or before a time at which the CDSS 800 is used to assess laser energy status and/or characteristic information of the working area, such as information about the kidney 112 or the calculi stone 114, as described above.
Based on one or more of the above input features, the processor performs an inference operation using the AI model to generate a control signal to activate fluid or suction, deactivate fluid or suction, modify the rate of fluid flow or suction, or predict when to provide such functions. For example, input interface 802 may deliver the image of the working area including the calculi stone 114 into an input layer of the AI model which propagates these input features through the AI model to an output layer. The AI model can provide a computer system the ability to perform tasks, without explicitly being programmed, by making inferences based on patterns found in the analysis of data. AI model explores the study and construction of algorithms (e.g., machine-learning algorithms) that may learn from existing data and make predictions about new data. Such algorithms operate by building an AI model from example training data in order to make data-driven predictions or decisions expressed as outputs or assessments.
There are two common modes for machine learning (ML): supervised ML and unsupervised ML. Supervised ML uses prior knowledge (e.g., examples that correlate inputs to outputs or outcomes) to learn the relationships between the inputs and the outputs. The goal of supervised ML is to learn a function that, given some training data, best approximates the relationship between the training inputs and outputs so that the ML model can implement the same relationships when given inputs to generate the corresponding outputs. Unsupervised ML is the training of an ML algorithm using information that is neither classified nor labeled, and allowing the algorithm to act on that information without guidance. Unsupervised ML is useful in exploratory analysis because it can automatically identify structure in data.
Common tasks for supervised ML are classification problems and regression problems. Classification problems, also referred to as categorization problems, aim at classifying items into one of several category values (for example, is this object an apple or an orange?). Regression algorithms aim at quantifying some items (for example, by providing a score to the value of some input). Some examples of commonly used supervised-ML algorithms are Logistic Regression (LR), Naive-Bayes, Random Forest (RF), neural networks (NN), deep neural networks (DNN), matrix factorization, and Support Vector Machines (SVM).
Some common tasks for unsupervised ML include clustering, representation learning, and density estimation. Some examples of commonly used unsupervised-ML algorithms are K-means clustering, principal component analysis, and autoencoders.
Another type of ML is federated learning (also known as collaborative learning) that trains an algorithm across multiple decentralized devices holding local data, without exchanging the data. This approach stands in contrast to traditional centralized machine-learning techniques where all the local datasets are uploaded to one server, as well as to more classical decentralized approaches which often assume that local data samples are identically distributed. Federated learning enables multiple actors to build a common, robust machine learning model without sharing data, thus allowing to address critical issues such as data privacy, data security, data access rights and access to heterogeneous data.
In some examples, the AI model may be trained continuously or periodically prior to performance of the inference operation by the processor. Then, during the inference operation, the patient specific input features provided to the AI model may be propagated from an input layer, through one or more hidden layers, and ultimately to an output layer that corresponds to the control signal to activate fluid or suction, deactivate fluid or suction, modify the rate of fluid flow or suction, or predict when to provide such functions. For example, the AI model 804 may be trained to implement the methods described in any of
Method examples described herein may be machine or computer-implemented at least in part. Some examples may include a computer-readable medium or machine-readable medium encoded with instructions operable to configure an electronic device to perform methods as described in the above examples. An implementation of such methods may include code, such as microcode, assembly language code, a higher-level language code, or the like. Such code may include computer readable instructions for performing various methods. The code may form portions of computer program products. Further, in an example, the code may be tangibly stored on one or more volatile, non-transitory, or non-volatile tangible computer-readable media, such as during execution or at other times. Examples of these tangible computer-readable media may include, but are not limited to, hard disks, removable magnetic disks, removable optical disks (e.g., compact disks and digital video disks), magnetic cassettes, memory cards or sticks, random access memories (RAMS), read only memories (ROMs), and the like.
Claims
1. An endoscopic system for coordinating operation of an ablation modality with at least one of an ancillary suction or irrigation modality, the endoscopic system comprising:
- controller circuitry, configured to issue a control signal to coordinate a timing or other parameter of at least one of the ancillary suction or irrigation modality with an ablation timing or other ablation parameter of ablation energy issued by the ablation modality toward an ablation target within a patient, wherein the control signal is issued automatically, without requiring direct user input to control the at least one of the ancillary suction or irrigation modality, to provide a relative increase of at least one of suction or irrigation in temporal coordination with issuance of the ablation energy by the ablation modality.
2. The endoscopic system of claim 1, further comprising:
- at least one of an imaging device, spectroscopic device, or other sensor to provide imaging, spectroscopic, or other characteristic information about at least one of the ablation target within the patient or an ablation target environment within the patient; and
- wherein the controller circuitry generates the control signal based at least in part on information from the sensor about at least one of the ablation target within the patient or an ablation target environment within the patient.
3. The endoscopic system of claim 2, wherein the controller circuitry:
- receives, from the imaging device, a first image of the ablation target environment;
- identifies dust or fragments of the ablation target from the first image; and
- generates the control signal based on characteristic information about the dust or fragments identified in the first image.
4. The endoscopic system of claim 3, wherein the characteristic information is a degree of blurriness caused by the dust of the ablation target in the first image.
5. The endoscopic system of claim 3, wherein the characteristic information is a number of fragments of the ablation target in the first image.
6. The endoscopic system of claim 3, wherein the characteristic information is an amount of dust or fragments of the ablation target settled in the ablation target environment in the first image.
7. The endoscopic system of claim 3, wherein the controller circuitry:
- receives, from the imaging device, a second image of the ablation target environment;
- identifies dust or fragments of the ablation target from the second image; and
- generates the control signal based on characteristic information about the dust or fragments identified in the second image.
8. The endoscopic system of claim 7, wherein the characteristic information is a change in the degree of blurriness caused by the dust of the ablation target between the first image and the second image.
9. The endoscopic system of claim 7, wherein the characteristic information is a trend in the degree of blurriness caused by the dust of the ablation target based on the first image and the second image.
10. The endoscopic system of claim 9, wherein the controller circuitry predicts when to generate the control signal based on the trend in the degree of blurriness caused by the dust of the ablation target based on the first image and the second image.
11. The endoscopic system of claim 7, wherein the characteristic information is a change in the number of fragments of the ablation target between the first image and the second image.
12. The endoscopic system of claim 7, wherein the characteristic information is a change in the amount of dust or fragments of the ablation target settled in the ablation target environment between the first image and the second image.
13. The endoscopic system of claim 2, wherein the characteristic information is an intraoperative pressure or intraoperative temperature of the ablation target environment.
14. The endoscopic system of claim 2, wherein the controller circuitry predicts a duration between a first control signal and a second control signal based on the characteristic information.
15. The endoscopic system of claim 1, wherein the control signal to coordinate the timing or other parameter of at least one of the ancillary suction or irrigation modality with the ablation timing or other ablation parameter of ablation energy issued by the ablation modality is issued with a temporal shift from the ablation timing ablation energy.
16. A method for coordinating operation of an ablation modality with at least one of an ancillary suction or irrigation modality, the method comprising:
- issuing a control signal to coordinate a timing or other parameter of at least one of the ancillary suction or irrigation modality with an ablation timing or other ablation parameter of ablation energy issued by the ablation modality toward an ablation target within a patient, wherein the control signal is issued automatically, without requiring direct user input to control the at least one of the ancillary suction or irrigation modality, to provide a relative increase of at least one of suction or irrigation in temporal coordination with issuance of the ablation energy by the ablation modality.
17. The method of claim 16, further comprising:
- receiving imaging, spectroscopic, or other characteristic information about at least one of the ablation target within the patient or an ablation target environment within the patient; and
- generating the control signal based at least in part on information from the sensor about at least one of the ablation target within the patient or an ablation target environment within the patient.
18. The method of claim 17, further comprising:
- receiving a first image of the ablation target environment;
- identifying dust or fragments of the ablation target from the first image; and
- generating the control signal based on characteristic information about the dust or fragments identified in the first image.
19. The method of claim 18, wherein the characteristic information is a degree of blurriness caused by the dust of the ablation target in the first image.
20. The method of claim 18, wherein the characteristic information is a number of fragments of the ablation target in the first image.
21. The method of claim 18, wherein the characteristic information is an amount of dust or fragments of the ablation target settled in the ablation target environment in the first image.
22. The method of claim 18, further comprising:
- receiving a second image of the ablation target environment;
- identifying dust or fragments of the ablation target from the second image; and
- generating the control signal based on characteristic information about the dust or fragments identified in the second image.
23. The method of claim 22, wherein the characteristic information is a change in the degree of blurriness caused by the dust of the ablation target between the first image and the second image.
24. The method of claim 22, wherein the characteristic information is a trend in the degree of blurriness caused by the dust of the ablation target based on the first image and the second image.
25. The method of claim 24, further comprising predicting when to generate the control signal based on the trend in the degree of blurriness caused by the dust of the ablation target based on the first image and the second image.
26. The method of claim 22, wherein the characteristic information is a change in the number of fragments of the ablation target between the first image and the second image.
27. The method of claim 22, wherein the characteristic information is a change in the amount of dust or fragments of the ablation target settled in the ablation target environment between the first image and the second image.
28. The method of claim 17, wherein the characteristic information is an intraoperative pressure or intraoperative temperature of the ablation target environment.
29. An endoscopic system for coordinating operation of an ablation modality with at least one of an ancillary suction or irrigation modality, the endoscopic system comprising:
- controller circuitry, configured to issue a treatment plan to coordinate a timing or other parameter of an ablation timing or other ablation parameter of ablation energy issued by the ablation modality toward an ablation target within a patient;
- at least one of an imaging device, spectroscopic device, or other sensor to provide imaging, spectroscopic, or other characteristic information about at least one of the ablation target within the patient or an ablation target environment within the patient; and
- wherein the controller circuitry generates the treatment based at least in part on information from the sensor about at least one of the ablation target within the patient or an ablation target environment within the patient.
30. The endoscopic system of claim 29, wherein the treatment plan further coordinates timing or other parameter of least one of the ancillary suction or irrigation modality.
Type: Application
Filed: Oct 18, 2022
Publication Date: Apr 27, 2023
Inventor: Jordan C. Avolos (Littleton, MA)
Application Number: 18/047,606